Zoledronic acid

Generic Name: Zoledronic acid

Brand Names: Aclasta, Reclast, Zometa, Zoledronic Acid Accord, Zoledronic acid Actavis, Zoledronic acid medac, Zoledronic acid Teva, Zoledronic Acid Hospira, Zoledronic acid Mylan

Drug Type: Small Molecule

Chemical Formula: C_₅H_₁₀N_₂O_₇P_₂

CAS Number: 118072-93-8

Unique Ingredient Identifier: 70HZ18PH24

Background: Zoledronic acid, or CGP 42'446, is a third generation, nitrogen containing bisphosphonate similar to ibandronic acid, minodronic acid, and risedronic acid. Zoledronic acid is used to treat and prevent multiple forms of osteoporosis, hypercalcemia of malignancy, multiple myeloma, bone metastases from solid tumors, and Paget’s disease of bone. Zoledronic acid was first described in the literature in 1994.

Zoledronic acid was granted FDA approval on 20 August 2001.

Indication: Zoledronic acid is indicated to treat hypercalcemia of malignancy, multiple myeloma, bone metastases from solid tumors, osteoporosis in men and postmenopausal women, glucocorticoid induced osteoporosis, and Paget's disease of bone in men and women. Zoledronic acid is also indicated for the prevention of osteoporosis in post menopausal women and glucocorticoid induced osteoporosis.

Associated Conditions: Bone Metastases, Hypercalcemia of Malignancy, Multiple Myeloma (MM), Osteoporosis, Osteoporosis caused by Glucocorticoid Treatment, Paget's Disease of Bone, Paget’s Disease

Associated Therapies: Bone Mineral Density

Clinical Trials

The Use of Zoledronic Acid to Complex Regional Pain Syndrome

Phase 2

Conditions: Complex Regional Pain Syndromes

Interventions: Drug: Placebo
Drug: Zoledronic acid

First Posted Date: 2013-02-11

Last Posted Date: 2013-02-11

Lead Sponsor: University of Sao Paulo General Hospital

Target Recruit Count: 40

Registration Number: NCT01788176

Locations: 🇧🇷
Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP, São Paulo, Brazil

Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis

Phase 4

Completed

Conditions: Post Menopausal Osteoporosis

Interventions: Biological: Denosumab
Drug: Zoledronic Acid
Drug: Placebo to Zoledronic Acid
Drug: Placebo to Denosumab

First Posted Date: 2012-11-26

Last Posted Date: 2020-03-10

Lead Sponsor: Amgen

Target Recruit Count: 643

Registration Number: NCT01732770

Locations: 🇪🇸
Research Site, Madrid, Spain

Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01F and T121E02F in Healthy Postmenopausal Women

Phase 1

Completed

Conditions: Healthy Postmenopausal Women

Interventions: Drug: Zoledronic acid
Drug: T121

First Posted Date: 2012-11-06

Last Posted Date: 2015-03-26

Lead Sponsor: Thar Pharmaceuticals, Inc

Target Recruit Count: 71

Registration Number: NCT01721993

Locations: 🇺🇸
Prism Clinical Research, St. Paul, Minnesota, United States

Zoledronic Acid in Cystic Fibrosis

Phase 4

Withdrawn

Conditions: Cystic Fibrosis

Interventions: Drug: Placebo
Drug: Zoledronic acid

First Posted Date: 2012-10-08

Last Posted Date: 2015-10-21

Lead Sponsor: Papworth Hospital NHS Foundation Trust

Registration Number: NCT01702415

Locations: 🇬🇧
Papworth Hospital NHS Foundation Trust, Cambridge, Cambridgeshire, United Kingdom

The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta

Phase 2

Terminated

Conditions: Osteogenesis Imperfecta

Interventions: Other: No active treatment
Drug: Zoledronic acid
Drug: Teriparatide

First Posted Date: 2012-09-05

Last Posted Date: 2021-06-25

Lead Sponsor: University of Aarhus

Target Recruit Count: 9

Registration Number: NCT01679080

Locations: 🇩🇰
Department of Endocrinology M, Odense, Denmark
🇩🇰
Department of endocrinology, Hvidovre, Denmark
🇩🇰
Osteoporosis clinic; department of endocrinology and metabolism, Aarhus, Aarhus C, Denmark

Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation

Phase 4

Completed

Conditions: Renal Osteodystrophy

Interventions: Drug: Zoledronic acid

First Posted Date: 2012-08-29

Last Posted Date: 2014-05-19

Lead Sponsor: University of Sao Paulo General Hospital

Target Recruit Count: 34

Registration Number: NCT01675089

Locations: 🇧🇷
Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, Brazil

Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer

Phase 1

Completed

Conditions: CLDN18.2-positive Gastric Adenocarcinoma
CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction
CLDN18.2-positive Adenocarcinoma of Esophagus

Interventions: Drug: IMAB362
Drug: Zoledronic acid
Drug: Interleukin-2 (3 million IU)
Drug: Interleukin-2 (1 million IU)

First Posted Date: 2012-08-24

Last Posted Date: 2024-11-14

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 29

Registration Number: NCT01671774

Locations: 🇱🇻
Riga East University Hospital, LLC, Latvian Oncology Center, Riga, Latvia
🇩🇪
Leipzig University Hospital, University Cancer Center (UCCL), Leipzig, Germany
🇩🇪
Institut für Klinische Forschung, Krankenhaus Nordwest GmbH, Frankfurt, Hessen, Germany

and more 6 locations

Zoledronic Acid in Acute Spinal Cord Injury

Phase 3

Completed

Conditions: Spinal Cord Injury

Interventions: Drug: normal saline 0.9%
Drug: Zoledronic acid

First Posted Date: 2012-07-17

Last Posted Date: 2023-05-23

Lead Sponsor: Thomas Jefferson University

Target Recruit Count: 16

Registration Number: NCT01642901

Locations: 🇺🇸
Thomas Jefferson University and Hospital, Philadelphia, Pennsylvania, United States

Bone Loss Treatment From Adjuvant Zoledronate Efficacy

Not Applicable

Terminated

Conditions: Breast Neoplasms
Bone Loss

Interventions: Drug: Zoledronate

First Posted Date: 2012-06-20

Last Posted Date: 2021-06-22

Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Target Recruit Count: 200

Registration Number: NCT01623908

Locations: 🇨🇳
Guangzhou First Municipal People's Hospital, Guangzhou, Guangdong, China
🇨🇳
Shenzhen Second Municipal People's Hospital, Shenzhen, Guangdong, China
🇨🇳
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China

and more 7 locations

Comparative Effect of Zoledronic Acid Versus Denosumab on Serum Sclerostin of Postmenopausal Women With Low Bone Mass

Not Applicable

Completed

Conditions: Postmenopausal Osteoporosis

Interventions: Drug: Denosumab
Drug: Zoledronic acid

First Posted Date: 2012-04-06

Last Posted Date: 2013-01-17

Lead Sponsor: Aristotle University Of Thessaloniki

Target Recruit Count: 91

Registration Number: NCT01572545

Locations: 🇬🇷
251 Hellenic Air Force Hospital, Athens, Attikis, Greece
🇬🇷
424 General Military Hospital, Thessaloniki, Greece
🇬🇷
Second Medical Clinic, Medical School, Aristotle University of Thessaloniki, Ippokration Hospital, Thessaloniki, Greece

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